S.C. Code Regs. § § 61-64.V.RHB 5.6

Current through Register Vol. 48, No. 10, October 25, 2024

Section 61-64.V.RHB 5.6 - Reinstatement Policy

A previously certified facility that has allowed its certificate to expire, that has been refused a renewal of its certificate by the FDA or the Department, or that has had its certificate suspended or revoked by the FDA or the Department, may apply for reinstatement. If reinstated, the facility will be eligible for a provisional certificate.

5.6.1 Unless prohibited from reinstatement under RHB 5.6.4, a facility applying for reinstatement shall:

5.6.1.1 Contact an FDA-approved accreditation body to determine the requirements for reapplication or accreditation;

5.6.1.2 Fully document its history as a previously provisionally certified or certified mammography facility, including the following information:

5.6.1.2.1 Name and address of the facility under which it was previously provisionally certified or certified;

5.6.1.2.2 Name of previous owner/lessor;

5.6.1.2.3 FDA facility identification number assigned to the facility under its previous certification; and

5.6.1.2.4 Expiration date of the most recent FDA provisional certificate or certificate.

5.6.1.3 Justify application for reinstatement of accreditation by submitting to the accreditation body a corrective action plan that details how the facility has corrected deficiencies that contributed to the lapse of, denial of renewal, or revocation of its certificate.

5.6.2 The Department may issue a provisional certificate to the facility if:

5.6.2.1 Following the Department's receipt of the accreditation body's decision that a facility has adequately corrected, or is in the process of correcting, pertinent deficiencies; and

5.6.2.2 The Department determines that the facility has taken sufficient corrective action since the lapse, denial, or revocation of its previous certificate.

5.6.3 After receiving the provisional certificate, the facility may lawfully resume performing mammography services while completing the requirements for certification.

5.6.4 If a facility's certificate was revoked on the basis of an act described in RHB 5.5, no person who owned or operated that facility at the time the act occurred may own or operate a mammography facility within two (2) years of the date of revocation.

S.C. Code Regs. § 61-64.V.RHB 5.6

Replaced and amended by State Register Volume 40, Issue No. 06, eff. 6/24/2016; State Register Volume 47, Issue No. 05, eff. 5/26/2023.